Changes from plenary report to adopted text

Added(e) indicate the existence of any commercially confidential information reported as such by the marketing authorisation holder pursuant to Article 128(1), point (e), and provide the marketing authorisation holder’s explanation of why that information is of a commercially confidential nature.

AddedWhere necessary, the competent authority of the Member State may request an extension of the deadline set by the Agency to comply with the request for information in accordance with point (a) of the first subparagraph.

Added7. Following the addition of a medicinal product to the Union list of critical medicinal products in accordance with Article 131 or any recommendations provided in accordance with Article 132(1), the Member States shall:

Added(a) provide any additional information that the Agency may request;

Added(b) provide additional relevant information to the Agency;

Added(c) comply and coordinate with any measures taken by the Commission pursuant to Article 134(1), point (a);

Added(d) take into account any MSSG recommendations referred to in Article 132(1);

Added(e) inform the Agency of any actions foreseen or taken in accordance with point (c) and (d) by that Member State, as well as the results of these actions.

Added8. Member States that take an alternative course of action in respect of paragraph 7, points (c) and (d), shall share the reasons for doing so with the Agency in a timely manner.

AddedArticle 128 Obligations of the marketing authorisation holder with regard to critical medicinal products

Added1. For the purposes of Article 127, paragraphs 1 and 3, and Article 131(1), the marketing authorisation holder as defined in Article 116(1) shall:

Added(a) submit the information requested in accordance with Articles 127(3), 130(2), point (b), and 130(4), point (b), to the competent authority concerned as defined in Article 116(1), without undue delay, using the tools, methods of and criteria for the monitoring and reporting established pursuant to Article 130(1), point (c), by the deadline set by that competent authority concerned;

Added(b) provide updates to the information provided in accordance with point (a) where necessary;

Added(c) justify any failure to provide any of the requested information;

Added(d) where necessary, submit a request to the competent authority concerned as defined in Article 116(1) for an extension of the deadline set by that competent authority in accordance with point (a), and

Added(e) indicate whether the information provided in accordance with point (a) contain any commercially confidential information, identify the relevant parts of that information having a commercially confidential nature and explain why that information is of such nature.

Added2. The marketing authorisation holder as defined in Article 116(1) authorisation shall be responsible for providing correct, not misleading, and complete information as requested by the competent authority concerned as defined in Article 116(1) and shall have the duty to cooperate and to disclose on their own motion any relevant information without undue delay to that competent authority and to update the information as soon as that information becomes available. [Am. 285]

AddedArticle 129 Obligations on other actors

AddedFor the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely mannerby the deadline set by the Agency and provide updates whenever necessary. [Am. 286]

AddedArticle 130 Role of the Agency

Added1. The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), ensure the following:

Added(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities and the availability of appropriate alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP), as well as other relevant stakeholders; [Am. 287]

Added(b) specify the procedures and criteria for establishing and reviewing the Union list of critical medicinal products referred to in Article 131;

Added(c) specify the tools, methods of and criteria for the monitoring and reporting provided for in Articles 127(6), point (a), and 128(1), point (a);

Added(d) specify the methods for the provision and review of MSSG recommendations referred to in Article 132, paragraphs 1 and 3.

AddedThe Agency shall publish the information referred to in points (b), (c) and (d) on a dedicated webpage on its web-portal.

Added2. Following the reports and information provided by the Member States and marketing authorisation holders in accordance with Article 127, paragraphs 2 and 6, and Article 128(1), the Agency, may request the relevant information from:

Added(a) the competent authority of the Member State concerned;

Added(b) the marketing authorisation holder of the medicinal product, including the shortage prevention and mitigation plan, referred to in Article 117 and Article 119(2); [Am. 288]

Added(c) other entities including other marketing authorisation holders, importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public.

AddedThe Agency, in consultation with the working party referred to in Article 121(1), point (c), shall report the information referred to in Article 127, paragraphs 2 and 6, and Article 128(1) to the MSSG.

Added3. For the purposes of Article 127(6), point (e), and Article 128(1), point (e), the Agency shall assess the merits of each confidentiality claim and protect commercially confidential information against unjustified disclosure.

Added4. Following the adoption of the Union list of critical medicinal products in accordance with Article 131, the Agency may request additional information from:

Added(a) the competent authority of the Member State concerned;

Added(b) the marketing authorisation holder as defined in Article 116(1);

Added(c) other entities including other marketing authorisation holders, importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public.

Added5. Following the adoption of the Union list of critical medicinal products in accordance with Article 131, the Agency shall report to the MSSG onassess any relevant information received from the marketing authorisation holder pursuant to Article 133 and the competent authority of the Member State in accordance with Article 127, paragraphs 7 and 8 and report on that information to the MSSG. [Am. 289]

Added6. The Agency shall make publicly available via the web-portal referred to in Article 104 the MSSG recommendations referred to in Article 132(1).

Added6a. Following the request by a Member State to use the Voluntary Solidarity Mechanism referred to in Article 132(1a), the Agency shall provide assistance to the MSSG and may:

Added(a) confirm that the conditions are met to launch the Voluntary Solidarity Mechanism;

Added(b) notify the members of the MSSG of the launch of the Voluntary Solidarity Mechanism;

Added(c) request from the members of the MSSG relevant information within a specific time limit;

Added(d) put the issuing country in contact with those Member States able to support them;

Added(e) organise meetings with the issuing Member States, the donating party and other relevant concerned parties;

Added(f) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicinal products. [Am. 290]

AddedArticle 131 The Union List of Critical Medicinal Products

Added1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c), and the Patients’ and Consumers’ Working Party (PCWP), the Healthcare Professionals’ Working Party (HCPWP) and the Industry Standing Group (ISG). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”). [Am. 291]

Added2. The MSSG mayshall propose updates to the Union list of critical medicines to the Commission, where necessary. [Am. 292]

Added3. The Commission, taking into account the proposal of the MSSG, shall adopt and update the Union list of critical medicinal products by means of an implementing act and communicate the adoption of the list and any updates to the Agency and the MSSG. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Added4. Following the adoption of the Union list of critical medicinal products in accordance with paragraph 3, the Agency shall immediately publish this list and any updates to this list on its web-portal referred to in Article 104.

AddedArticle 132 Role of the MSSG

Added1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on manufacturing capacity, on reorganisation of manufacturing capacity, diversification of suppliers and, inventory management, establishment of minimum safety stock and, if necessary, redistribution of available stock among Member States under the Voluntary Solidarity Mechanism to address urgent needs, as well as pricing and procurement mechanisms and measures and, where appropriate, the use of regulatory flexibilities without lowering safety and efficacy standards. [Am. 293]

Added1a. The MSSG shall coordinate the Voluntary Solidarity Mechanism to allow Member States to request assistance in obtaining stocks of a medicinal product during critical shortages. The MSSG shall specify the procedures and criteria to launch the Voluntary Solidarity Mechanism in consultation with the Member States, the Agency and the Commission. [Am. 294]

Added1b. Following the update of the Union list of critical medicinal products, the MSSG shall assess the shortage prevention plan of the medicinal products present on the list. [Am. 295]

Added2. The MSSG shall amend its rules of procedure, and the rules of procedure of the working party referred to in Article 121(1), point (c), in accordance with the tasks set out in this section.

Added3. Following the report pursuant to Article 130(5), the MSSG shall review its recommendations in accordance with the methods referred to in Article 130(1), point (d).

Added4. The MSSG may request the Agency to request further information from the Member States or marketing authorisation holder of the medicinal product as defined in Article 116(1) and included on the Union list of critical medicinal products or other relevant entities referred to in Article 129.

AddedArticle 133 Obligations on the marketing authorisation holder after the MSSG recommendations

AddedFollowing the addition of a medicinal product to the Union list of critical medicinal products in accordance with Article 131(3) or any recommendations provided in accordance with Article 132(1), the marketing authorisation holder as defined in Article 116(1) of a medicinal product on that list or subject to those recommendations shall:

Added(a) provide any additional information that the Agency may request;